美国保健食品监管及标准现状

Current status of health food regulation and standards in the United States

美国保健食品又称为膳食补充剂,是指以维生素、矿物质、氨基酸、草药(或其他草本植物)或以上成分经浓缩、配方、提取或混合形成的产品,主要由美国食品和药物管理局(Food and Drug Administration, FDA)负责监管。美国保健食品与我国的保健食品在产品类别、原料及形态等方面具有一定的相似性,因此美国保健食品目前的监管和标准现状对于我国保健食品有相当的借鉴意义。本文以美国保健食品(膳食补充剂)相关监管法规、产品标准作为研究对象,重点分析了美国保健食品在范畴、产品、原料、功能声称、标签、生产经营等方面的规定。同时介绍和分析美国膳食补充剂药典(dietary supplement compendium, DSC)的主要内容,为完善我国保健食品的监管体系、理顺监管职责、提升标准水平提供了技术依据。

American health food,also known as dietary supplements,refers to the products formed by concentration,formulation,extraction or mixing of vitamins,minerals,amino acids,herbs(or other herbs) or above,which are mainly supervised by the Food and Drug Administration of the United States.There are some similarities between American health food and Chinese health food in product categories,raw materials and forms,so the current supervision and standard of American health food can be used for reference in China.In this paper,the regulations and product standards of American health food(dietary supplements) were taken as the research object.The regulations of category,product,raw material,function claim,label,production and management of health food in the United States were emphatically analyzed.Meanwhile,the main contents of the Dietary Supplement Compendium(DSC) in the United States were introduced and analyzed,which provided a technical basis for improving the regulatory system of health food in China,rationalizing the regulatory responsibilities and improving the standard level.